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March 2012

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Subject:
From:
Byron Lewis <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 7 Mar 2012 08:44:47 -0800
Content-Type:
text/plain
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Lim,
á
I think you will have issues trying to pass a PQ the way you plan to set it up, if you are using a probe for liquid particle counts. The trouble is that particles have different densities and some float, some sink, etc at different rates, so whatever you buy as standard size particles is unlikely to be representative of the particles you are trying to measure in your solutions. Mixing can help make the solution more homogenous, but any bubbles are an issue with particle counts.
á
In this case I would follow the USP method for liquid particle counts and only make your PQ about proving you can meet its requirements. I don't think you need to test standard size particles to do that.
á
Regards,
Byron



--- On Tue, 3/6/12, Lim, Chin Chuan <[log in to unmask]> wrote:


From: Lim, Chin Chuan <[log in to unmask]>
Subject: [PMFLIST] PQ for Liquid Particle Counter
To: [log in to unmask]
Date: Tuesday, March 6, 2012, 6:32 AM


Dear Forum,

Anyone in the forum have the experience in performing the PQ for liquid particle counter?

The vendor of my LPC was only able to perform IQ and OQ for the machine.

I am planning to test on the Sensor Resolution and Counting Accuracy on the particle size of 1Ám, 10Ám and 25 Ám (as per the particle size that I need to test for my product).

Is this a right approach?

But I am facing difficulties to find the standard solution of that particular size. Where can i get the standard? My current location is in Malaysia.

Thanks a lot.


Regards,

Lim Chin Chuan
Microbiologist


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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

MicroBioLogics, Inc. - http://www.microbiologics.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Steris - http://www.sterislifesciences.com/

Veltek Associates, Inc - http://www.sterile.com

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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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